FDA Approves Ready-to-Use Subcutaneous Bortezomib Formulation

Microscopic photorealistic image of myeloma cells - Generated with Google Gemini AI

• The FDA has approved the first ready-to-use administration of subcutaneous bortezomib (Boruzu).
• This new formulation minimizes the compounding preparation required for standard bortezomib administration.
• This formulation is anticipated to launch in the second quarter of 2025.

A new, ready-to-use, subcutaneous version of bortezomib has been approved by the FDA.¹

Reconstitution before use is not required, in contrast with the branded bortezomib product Velcade, which is a lyophilized powder. The ready-to-use formulation offers greater flexibility and speed of administration.

"We are building a distinct branded oncology injectable portfolio. The approval of Boruzu is our fourth 505(b)(2) injectable approval this year. These ready-to-use injectable presentations are important innovations for oncology providers as they reduce the pharmacy preparation steps for clinicians. We look forward to bringing more branded oncology products to the market for providers while expanding access for patients," said Sean McGowan, vice president of biosimilars and branded oncology at Amneal Pharamaceuticals, in a press release.

Lymphoma cell: © Dr_Microbe - stock.adobe.com

This bortezomib injection is indicated for use in adult patients with multiple myeloma or mantle cell lymphoma.² A phase 3 noninferiority study (NCT00722566) evaluated the efficacy and safety of subcutaneous vs intravenous bortezomib in patients with multiple myeloma. A total of 222 patients with bortezomib-naive relapsed multiple myeloma were included and randomly assigned 2:1 to receive 1.3 mg/m² of subcutaneous (n = 148) or intravenous (n = 74) bortezomib. After 4 cycles, the overall response rate (ORR) in the subcutaneous bortezomib arm was 43% vs 42% in the intravenous arm. In the subcutaneous arm, 7% of patients achieved a complete response (CR) and 35% achieved a partial response (PR) compared with 8% and 34% in the intravenous arm, respectively.

Regarding safety, the most commonly reported adverse effects from the subcutaneous bortezomib administration were asthenic conditions, diarrhea, nausea, constipation, peripheral neuropathy, vomiting, pyrexia, thrombocytopenia, psychiatric disorders, anorexia/decreased appetite, neutropenia, neuralgia, leukopenia, and anemia.

Comparatively, the most commonly reported adverse events with intravenously administered bortezomib include nausea, diarrhea, thrombocytopenia, peripheral neuropathy, fatigue, neuralgia, anemia, leukopenia, constipation, vomiting, lymphopenia, rash, pyrexia, and anorexia.³

REFERENCES:

1. Amneal and Shilpa announce US FDA approval of BORUZU^TM, the first ready-to-use version of bortezomib for subcutaneous administration. News release. Amneal Pharamaceuticals. September 5, 2024. Accessed September 6, 2024. https://tinyurl.com/3ajc6cn7

2. Prescribing information. Amneal Pharmaceuticals. Accessed September 6, 2024. https://tinyurl.com/4sy6ut9p

3. Velcade (bortezomib). International Myeloma Foundation. Updated September 27, 2021. Accessed September 6, 2024. https://www.myeloma.org/velcade-bortezomib